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510(k) Data Aggregation

    K Number
    K202972
    Device Name
    Anterior Cervical Plate System
    Date Cleared
    2020-11-24

    (55 days)

    Product Code
    Regulation Number
    888.3060
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    Applicant Name (Manufacturer) :

    Nutech Spine and Biologics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nutech Spine and Biologics Anterior Cervical Plate System is interior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
    Device Description
    The Anterior Cervical Plate System consists of single level titanium bone plates of various sizes and titanium bone screws in various diameters and lengths to allow for patient specific configurations. The triangular shape of the plate allows for adjacent level fusion without removal of prior Nutech Cervical Plates. Implants are made from Ti 6AI4V ELI, per ATSM F136. The instrumentation allows for simple preparation and placement of the implant construct.
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